MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES),; CATHETER, STEERABLE

Model Number	401932
Medical Device Problem Codes	Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
During a pulmonary vein isolation procedure, while attempting to position the catheter within the heart, the catheter became lodged inside the eustachian ridge.Right internal jugular vein access was obtained and a non-abbott catheter (deflectable st-sf f-curve biosense webster) was used to snare the loop of the catheter from above.The catheter was removed successfully via the femoral vein and a non-abbott catheter (biosense webster cs ez steer) to complete the procedure with no further adverse consequences to the patient.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES),
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17778365
• Report Number: 2182269-2023-00042
• Device Sequence Number: 5493435
• Product Code: DRA
• UDI-Device Identifier: 05414734202626
• UDI-Public: 05414734202626
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K022380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 401932
• Device Lot Number: 9022469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 83 KG